Registration Dossier
Registration Dossier
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EC number: 279-368-1 | CAS number: 80019-42-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment reports
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Reports of the Scientific Committee on Cosmetology
- Author:
- Commission of the European Communities
- Year:
- 1 988
- Bibliographic source:
- Scientific Committee on Cosmetology (seventh series), European Communities, 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To determine the skin sensitizing potential of the test chemial in guinea pig.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- no data available
Test material
- Reference substance name:
- Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 223-098-9
- EC Name:
- Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 3734-67-6
- Molecular formula:
- C18H13N3Na2O8S2
- IUPAC Name:
- disodium 5-acetamido-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Reference substance name:
- Acid Red 1 (Red 2G)
- IUPAC Name:
- Acid Red 1 (Red 2G)
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name of test material (as cited in study report): Acid Red 1 [Red 2G]
Molecular formula : C18H15N3O8S2.2Na
Molecular weight : 509.426 g/mol
Smiles notation : c12c(cc(S(=O)(=O)[O])c(c2O)\N=N\c2ccccc2)cc(S(=O)(=O)[O])cc1NC(C)=O.[Na+].[Na+]
InChl : 1S/C18H15N3O8S2.2Na/c110(22)1914913(30(24,25)26)711815(31(27,28)29)17(18(23)16(11)14)2120125324612;;/h29,23H,1H3,(H,19,22)(H,24,25,26)(H,27,28,29);;/q;2*+1/p2/b2120+;;
Substance type: Organic
Physical state: Solid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 ml of a 7.5% solution in saline
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 ml of a 7.5% solution in saline
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- no data available
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
No. of exposures: 2 times 4 intradermal injections
Exposure period: No data
Test groups: No data
Control group: No data
Site: No data
Frequency of applications: 2 times
Duration: No data
Concentrations: 0.1 ml of 7.5% solution in saline
B. CHALLENGE EXPOSURE
No. of exposures: single
Day(s) of challenge: 14 days after second intradermal injection
Exposure period: No data
Test groups: No data
Control group: No data
Site: No data
Concentrations: 3% solution in saline
Evaluation (hr after challenge): No data - Challenge controls:
- no data available
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- no data available
Results and discussion
- Positive control results:
- no data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 7.5% in saline
- No. with + reactions:
- 0
- Clinical observations:
- No sensitization observed
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
The intradermal induction and challenge did not reveal any signs of sensitisation.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- The test chemical was considered to be non sensitizing after challenge exposure in guinea pig.
- Executive summary:
A sensitization test was carried out in guinea pigs to determined the sensitizing potential of the test chemical. Guinea pigs were given two times 4 intradermal injections of 0.1 ml of a 7.5% solution in saline during the induction phase.14 days after second injection, a challenge exposure was conducted.
In the challenge exposure, single intradermal injection of a 3% solution in saline was administered to the guinea pigs.
Signs of sensitization were not observed. Hence, the test chemical was considered to be non sensitizing after challenge exposure in guinea pig.
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